Performance of Crohn’s disease Clinical Trial Endpoints based upon Different Cutoffs for Patient Reported Outcomes or Endoscopic Activity: Analysis of EXTEND Data
Author(s) -
Brian G. Feagan,
William J. Sandborn,
Paul Rutgeerts,
Barrett G. Levesque,
Reena Khanna,
Bidan Huang,
Qian Zhou,
JenFue Maa,
Kori Wallace,
Ana P. Lacerda,
Roopal Thakkar,
Anne Robinson
Publication year - 2018
Publication title -
inflammatory bowel diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.932
H-Index - 146
eISSN - 1536-4844
pISSN - 1078-0998
DOI - 10.1093/ibd/izx082
Subject(s) - medicine , clinical endpoint , adalimumab , placebo , crohn's disease , clinical trial , post hoc analysis , colonoscopy , randomized controlled trial , inflammatory bowel disease , endoscopy , gastroenterology , disease , pathology , colorectal cancer , alternative medicine , cancer
Clinical trial endpoints for Crohn's disease (CD) activity correlate poorly with mucosal inflammation; to assess treatment efficacy, patient-reported outcomes and endoscopic assessments are preferred. This study assessed the impact on treatment efficacy estimations of using different definitions of clinical and endoscopic remission and endoscopic response, and of using site- or central-based endoscopy evaluation.
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